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FDA 510(k)

BINAS LUTEINIZING HORMONE IRMA TEST KIT

K-Number: K883306 · 1988-10-06

ApplicantBinax, Inc.
Decision Date1988-10-06
Product CodeJIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BINAS LUTEINIZING HORMONE IRMA TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Binax, Inc.. It received FDA 510(k) clearance on 1988-10-06 under 510(k) number K883306. The device is classified under product code JIT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BINAS LUTEINIZING HORMONE IRMA TEST KIT?

BINAS LUTEINIZING HORMONE IRMA TEST KIT is a medical device that received FDA 510(k) clearance on 1988-10-06. The listed applicant is Binax, Inc.. The 510(k) number is K883306.

When did BINAS LUTEINIZING HORMONE IRMA TEST KIT receive FDA 510(k) clearance?

BINAS LUTEINIZING HORMONE IRMA TEST KIT received FDA 510(k) clearance on 1988-10-06, under 510(k) number K883306.

Who is the listed applicant for BINAS LUTEINIZING HORMONE IRMA TEST KIT?

The FDA 510(k) record lists Binax, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BINAS LUTEINIZING HORMONE IRMA TEST KIT?

The FDA product code for BINAS LUTEINIZING HORMONE IRMA TEST KIT is JIT.

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Related Devices (Code: JIT)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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